NVM5

Basic Information

• Brand Name: NVM5
• Primary DI: 00887517462930
• Version / Model: 1616240
• Company Name: Nuvasive, Inc.
• Labeler DUNS: 053950783
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-26
• Public Version: 4
• Public Version Date: 2023-12-18
• Public Version Status: Update
• Public Device Record Key: 792bd75d-a791-4052-ab96-cc73d4767229

Device Description

NVM5 Corkscrew Electrode, S.D. SSEP

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PDQ	Neurosurgical nerve locator	Ear, Nose, Throat	874.1820	2
OLO	Orthopedic stereotaxic instrument	Neurology	882.4560	2
ETN	STIMULATOR, NERVE	Ear, Nose, Throat	874.1820	2
IKN	Electromyograph, diagnostic	Physical Medicine	890.1375	2
HAW	Neurological stereotaxic Instrument	Neurology	882.4560	2
GWF	STIMULATOR, ELECTRICAL, EVOKED RESPONSE	Neurology	882.1870	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61020	Analytical non-scalp cutaneous electrode	An electrical conductor designed to be attached to the skin surface of a patient outside of the hair line (i.e., non-scalp) to conduct electrical signals to/from a parent device for electrophysiological recording/monitoring [e.g., electromyography (EMG), evoked potentials (EP), nerve conduction study (NCS), bioelectrical impedance]; it is not primarily intended for diagnostic electrocardiography (ECG) or electroencephalography (EEG). It typically consists of a small rectangular tab or cup/disk with a conductive surface, which may include a lead wire. This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00887517462930	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K143641	000